Vice President, Regulatory Affairs Job at Cabaletta Bio Inc (Philadelphia)

Vice President, Enzyme Therapies, Clinical Development

The Vice President, Enzyme Therapies, Clinical Development is the head of Resear...

Location

United States , San Rafael

Salary:

307840.00 - 461760.00 USD / Year

BioMarin Pharmaceutical

Expiration Date

Until further notice

Requirements

M.D. or M.D./PhD degree
15+ years of clinical research and development experience within pharmaceutical/biotech industry
8+ years in a leadership role leading and managing teams
Significant experience in late-stage clinical development within the biopharma industry
Demonstrated leadership of successful regulatory filings (NDA/BLA/MAA) for global clinical programs
Oversite of clinical development of a therapeutic area or multiple assets within a disease area
Excellent track record in building and growing high-performing teams
Excellent leadership and organizational skills, written and verbal communication skills, and interpersonal skills
Ability to effectively influence diverse internal and external customer groups at various levels
Demonstrated strategic and critical thinking, dynamic leadership, and team-building skills

Job Responsibility

Lead the development and execution of the Enzyme Therapies BU pipeline strategy
Oversee strategic selection and prioritization of assets
Build and lead a high-performing, cross-functional development strategy team
Partner with clinical, regulatory, commercial, medical, portfolio strategy, and business development functions
Drive late-stage clinical development, study design, and execution for pivotal and post-marketing studies
Work closely with business development to evaluate and integrate external innovation opportunities
Provide scientific and medical leadership for global regulatory filings and interactions
Serve as the primary communication liaison between the BU Leadership Team and R&D Leadership Team
Ensure key BU portfolio deliverables are planned, executed, and measured
Maintain strong relationships with investigators, regulators, key opinion leaders, and other external stakeholders

What we offer

Discretionary annual bonus
Discretionary stock-based long-term incentives
Paid time off
Company-sponsored medical, dental, vision, and life insurance plans

Fulltime

Associate Vice President, Clinical Data Management

The Associate Vice President, Clinical Data Management is a member of the Global...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Bachelor’s or master’s degree with 25+ years of data management experience
10 to 15 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
Experience within clinical data management, regulatory compliance, and strategic leadership within a pharmaceutical, biotech, or CRO environment
Expertise in GCP, ICH, FDA, EMA regulations, data governance, and clinical trial data standards (CDISC, SDTM)
Experience within cross-functional collaborations, leadership, and strategic planning skills, ensuring operational excellence and compliance while driving innovation in data management to support Amgen’s global clinical development efforts
Expertise in AI/ML-driven data management solutions, automation, and advanced analytics
Understanding of clinical data standards (CDISC, SDTM, ADaM)
Experience leading regulatory submissions, including NDA/BLA/MAA filings and advisory committee interactions
Proven ability to drive organizational change, optimize processes, and implement lean principles in clinical data management
Cross-functional collaboration experience with clinical operations, regulatory affairs, biostatistics, and R&D teams

Job Responsibility

Develop and drive the global data management strategy in alignment with clinical development objectives and corporate goals
Provide strategic and operational leadership to the Clinical Data Management (CDM) function across all clinical programs and phases
Lead innovation initiatives, including the implementation of development integration programs and the adoption of cutting-edge technologies to enhance data workflows
Represent Clinical Data Management in executive leadership discussions, regulatory interactions, and industry forums
Establish and enforce robust clinical data governance models, policies, and risk mitigation strategies to ensure quality and compliance
Make final decisions regarding standard operating procedures (SOPs), CDM best practices, and process optimization
Engage key stakeholders and ensure timely resolution on critical data integrity and regulatory compliance issues
Serve as the primary CDM representative during regulatory inspections and audits, with responsibility for final decisions on findings, responses, and corrective actions
Influence cross-functional clinical development, operational, and regulatory strategies through data-driven insights and analytics
Partner closely with Clinical Program Operations, Regulatory, Biostatistics, and R&D to ensure seamless integration and alignment of clinical data

Vice President, Market Access, Commercial

Reporting to the Chief Commercial Officer, the Vice President, Market Access, Co...

Location

United States , Philadelphia

Salary:

Not provided

Cabaletta Bio Inc

Expiration Date

Until further notice

Requirements

An advanced degree (Master's or Doctorate) in life sciences, business/finance, or a related field is preferred
15+ years of progressive experience in biopharma market access, pricing, health economics, or related areas, with a significant track record in senior leadership roles
Specific experience in cell and/or gene therapy, or launching other complex, rare disease therapies, is critical
Exceptional strategic thinking, commercial acumen, communication, negotiation, and leadership skills
A robust network within the biopharmaceutical industry, including relationships with key payers, hospitals and related thought leaders is vital
Strong team orientation and passion for continuous self-development

Job Responsibility

Develop and implement global and/or U.S. market access strategies that align with corporate goals and drive successful product launches
Cultivate relationships and lead negotiations with key stakeholders, including national and regional payers, government agencies (e.g., CMS), hospitals and policymakers, to secure and maintain optimal coverage and reimbursement
Lead the creation and communication of the product's value story, including clinical, economic, and health-related quality of life (HRQOL) value propositions, using evidence generation plans in partnership with Medical Affairs
Define and execute U.S. and global pricing strategies, balancing market competitiveness and access goals, while adhering to federal and state regulations
Partner with R&D, Commercial, Medical Affairs, Regulatory, Finance, and Supply Chain teams to ensure market access strategies are integrated into all stages of product development and commercialization
Proactively navigate evolving healthcare legislation and reimbursement models and optimize site-of-care strategies and provider logistics for the unique delivery of cell therapies (e.g., hospital-administered or specialty distribution models)
Establish and build a market access organization, overseeing a team of market access professionals and managing external advisors and consultants

What we offer

health and retirement, PTO, and stock option plans

Dean of the College of Nursing

Augusta University invites expressions of interest and nominations for the posit...

Location

United States , Augusta

Salary:

Not provided

Buffkin / Baker

Expiration Date

Until further notice

Requirements

Registered nurse with a terminal graduate degree in nursing
Academic credentials for appointment at rank of at least Associate Professor
Ph.D. or DNP recommended
Relevant academic administrative experience
Record of scholarly achievement commensurate with appointment at rank of Professor
Executive leadership experience ideally within college of nursing, academic health center, or complex healthcare/research enterprise
Proven record of effective leadership with documented, measurable outcomes
Financial and budgeting experience including oversight of complex academic budgets
Advocacy and policy experience including engagement with healthcare policy
Philanthropic and fundraising experience

Job Responsibility

Lead strategic growth in academic and research programs
Foster interprofessional collaboration across Augusta University colleges
Cultivate community partnerships
Serve as key advocate for addressing Georgia's nursing workforce needs
Oversee college's teaching, research, and service mission
Provide strategic direction and set priorities for resource allocation
Work to generate new funding to support future growth
Ensure Augusta University achieves key objectives of university's strategic plan
Represent College of Nursing within university, broader community, and external partners
Champion innovation and technology to amplify impact

Vice President, Payors & Evidence

The Vice President, Payors and Evidence, is a key member of the U.S. leadership ...

Location

United States , Minneapolis

Salary:

232000.00 - 320000.00 USD / Year

Coloplast

Expiration Date

Until further notice

Requirements

Bachelor’s or Master´s degree in Business, Health Sciences, Management or Health Policy required
12+ years of experience – including specific experience with medical devices and/or health policy
Proven experience to develop Medicare coding, coverage, payment strategies for medical products reimbursed in inpatient, outpatient or in the community settings
Track record of cross functional collaboration with clinical or medical affairs teams in US and/or Europe in support of reimbursement and commercial success
Minimum of 5 years of successful management experience, leading senior level management, professionals and highly skilled employees
Proactive style and a strategic business sense that will allow them to develop creditability across the organization
Ability to consistently work, manage and lead with ethical integrity
Willingness and ability to travel –30%, some international travel expected.

Job Responsibility

Reimbursement including Government and Public Affairs
Market Access
Medical Affairs
Regulatory Compliance
Organizational Leadership

What we offer

Comprehensive medical, dental, and vision insurance plans
Company sponsored wellness programs and mental health resources
Paid leave of absence for qualifying events
Generous paid parental leave for both birthing and non-birthing parents
Competitive 401(k) plan with company match that vest immediately
Financial planning services
Corporate discount programs for goods and services
Generous paid time off
Flexible work hours
Flexible work arrangement options

Fulltime

Vice President, Biostatistics

The Vice President, Biostatistics is a key enterprise leader responsible for set...

Location

United States , Philadelphia

Salary:

Not provided

Cabaletta Bio Inc

Expiration Date

Until further notice

Requirements

PhD or Master’s degree in Biostatistics, Statistics, or related field
10+ years of relevant experience in biotech/pharmaceutical R&D, including leadership of statistical strategy for early and late-stage clinical programs
At least 7 years leading Biostatistics teams, including management of statisticians, programmers, and/or data management groups
Demonstrated success in shaping statistical strategy for pivotal trials and regulatory submissions
Proven ability to influence senior stakeholders, navigate ambiguity, and drive alignment across cross-functional teams
Strong track record of contributing to late-stage development/regulatory submissions with BLA experience strongly preferred
Deep understanding of global regulatory guidelines, data requirements, clinical operations interfaces, and inspection readiness
Exceptional communication skills with ability to translate complex statistical concepts into clear, actionable insights for diverse audiences
Experience managing departmental budgets, vendor relationships, and technical infrastructure
Highly collaborative, with strong interpersonal skills and the ability to build trust across teams

Job Responsibility

Lead and develop the Biostatistics and Data Management functions, developing a long-term vision, operating model, and high-performance culture
Recruit, mentor, and inspire the team to ensure organizational capability scales with the company’s clinical portfolio
Serve as a strategic advisor to executive leadership on statistical risk, trial feasibility, portfolio trade-offs, and data-driven decision making
Provide expert statistical input into clinical development strategy, protocol concepts, study design, and endpoint selection to optimize probability of technical and regulatory success
Drive innovative statistical approaches, adaptive designs, and data-driven methodologies to accelerate development timelines and enhance the robustness of clinical findings
Ensure all statistical strategies align with regulatory expectations and meet the needs of future submissions, inspections, and commercial planning
Oversee development and execution of statistical analysis plans, data review strategies, and inferential methodologies for all clinical studies
Ensure the integrity, quality, reproducibility, and validation of statistical analyses, including submission-ready documentation
Partner cross-functionally with Clinical Development, Clinical Operations, Regulatory Affairs, Medical Affairs, CMC, and other teams to ensure seamless execution and data-driven decision making
Provide statistical leadership for regulatory interactions and submissions, including authoring and reviewing statistical components of BLAs, briefing packages, responses, and advisory committee materials

What we offer

health and retirement
PTO
stock option plans

Government Relations Vice President

The Government Relations VP will be a key part of the UK Government Relations te...

Location

United Kingdom , London

Salary:

Not provided

Barclays

Expiration Date

Until further notice

Requirements

Proven experience operating at board or ExCo level within financial services, ideally with exposure to prudential regulation and complex regulatory landscapes
Background in a large corporate, civil service department, or HM Treasury, with a strong understanding of government processes and policy development
Demonstrated capability in managing senior‑level stakeholder engagement, with the confidence and credibility to represent the organisation with regulators, government bodies, and industry groups
Exceptional communication, strategic briefing, and policy‑shaping skills, with the ability to translate technical and regulatory issues into clear, actionable insights for senior leaders
Strong connectivity with policy makers, trade associations and peers at other institutions.

Job Responsibility

Management of relationships with governments, politicians, regulators and relevant stakeholders to advocate the bank’s interest/position in policy discussions
Development and execution of external advocacy and policy strategy that shapes how the bank responds to emerging policy trends so that its interests are communicated
Collaboration with and advice to stakeholders including senior managers, industry groups, think tanks, agencies and others to gain policy insights and determine policy goals
Development of advocacy campaigns and initiatives that support the bank’s policy efforts through public and private engagements, education, and lobbying
Monitoring and evaluation of successful advocacy initiatives and contribute to future improvements by looking into new markets and sectors.

Fulltime

Vice President, Licensure, Accreditation and Enrollment

As the enterprise leader, the VP is responsible for licensure, accreditation, an...

Location

United States , Brentwood

Salary:

Not provided

Kirby Bates Associates

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Healthcare Administration, Business Administration, Public Health, Regulatory Affairs, or related field
10+ years of experience in healthcare licensing, accreditation, enrollment, or credentialing
7+ years of progressive leadership experience building and governing enterprise‑level, multi‑state regulatory compliance programs
Deep knowledge of CMS supplier standards, DMEPOS accreditation, and multi‑state licensing requirements
Direct experience with TJC, ACHC, HQAA, or comparable accreditation bodies
Strong analytical skills, executive presence, and systems-thinking capability

Job Responsibility

Develop and execute the enterprise strategy for a national organization operating in 48 states and 150 locations
Direct the design and implementation of centralized tracking systems for licenses, certifications, and accreditation statuses
Serve as the executive owner of the accreditation strategy, including survey readiness, corrective action processes, and prevention of deficiencies
Oversee internal audit and mock survey programs to validate regulatory controls and readiness
Executive liaison with CMS, state agencies, and accreditation bodies during surveys and investigations
Translate complex regulations into enterprise guardrails and operational requirements
Implement monitoring systems, early‑warning indicators, audits, and root‑cause remediation to manage emerging regulatory risk
High‑visibility role responsible for leading, coaching, and evaluating department leaders while fostering a culture of performance, compliance, and continuous improvement

Fulltime

Vice President, Regulatory Affairs

Cabaletta Bio Inc

Location:
United States , Philadelphia

Category:
Research and Development

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
February 03, 2026

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